Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000567426
Ethics application status
Approved
Date submitted
7/05/2025
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a pharmacist-led intervention on medication adherence and the quality use of medicines in people using clozapine attending the Colombo south teaching hospital, Sri Lanka
Scientific title
The effect of a pharmacist-led intervention on medication adherence and the quality use of medicines in people using clozapine attending the Colombo south teaching hospital, Sri Lanka
Secondary ID [1] 314393 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with Schizophrenia 337401 0
Condition category
Condition code
Mental Health 333780 333780 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
Medication history and reconciliation
For each outpatient included in the study, the PhD candidate will obtain the most accurate best possible medication history, beginning with the most recent medication list available on the clinic’s medication card. This card, which the patient takes to the pharmacy to obtain their medications, includes a medication list covering the previous 5–6 months. The list was initially compiled by the treating doctor in accordance with standard hospital procedures, the clinical knowledge, skills and experience and was supplemented with additional sources, including: (i) handwritten medical records kept by the patient, (ii) handwritten medical records maintained at the hospital for individual patients who regularly attend the clinic, and (iii) information gathered through patient conversations or interviews conducted during clinic visits or upon admission. This whole appointment will take approximately 30 minutes including history taking, assessing their level of understanding of medications and delivering patient education. One meeting will be conducted with each patient every four weeks for four months.

A structured conversation with the patient or carer will be conducted to clarify current medication use. For each medicine included in the medication list, the current use, dosage, and time of administration will be checked. The PhD candidate will conduct a comprehensive medication reconciliation based on the obtained medication history, patient records, hospital records, and the clinic’s medication card and record any discrepancies identified. Following the medication reconciliation, the physical health check prompt will be used as a conversation starter and their physical health, mental wellbeing and quality of life will be assessed.

Any discrepancies identified during the reconciliation process, as well as any physical health or mental well-being, quality of life issues, will be documented in a adapted medication action plan (MAP) (1). The MAP is a validated tool used in Australia to record a patient’s medication regimen prior to hospital presentation and to document any issues with the regimen following hospital admission or at each clinic visit. It prioritises issues identified by the pharmacist, focusing on urgent clinical concerns, such as cases where a patient has stopped taking clozapine. For each identified issue, the pharmacist includes proposed actions such as medication dose adjustments, omission of any medication if it’s unnecessary or addition of medication if any untreated condition identified, for example if the patient is really struggling out of constipation, the pharmacist can suggest to the treating team that patient’s dose of medication for constipation can be increased or can be change another group of medication which is available at the hospital and the MAP provides space for the treating doctor to document responses to these recommendations, creating a collaborative, trackable plan. This MAP will be shared with their treating doctor, ensuring that any discrepancies between the clinic’s medication card and the best possible medication list from the medication history, along with any additional physical health concerns, are communicated to the treating doctor.

Based on the presentation of the patient, the treating doctor will be adjusted the prescription in order to provide optimal therapy. The detected discrepancies will be classified according to Pharmaceutical Care Network Europe classification (PCNE) V 9.1 (2).

In Sri Lanka, clozapine treatment in state hospitals follows the Ceylon Hospital Formulary, which is adapted from UK guidelines based on the availability of medications in the country. Therefore, the PhD candidate will follow the Ceylon Hospital Formulary, the British National Formulary (BNF), and the hospital’s clozapine treatment guideline. Furthermore, the PhD candidate will also observe whether the hospital guideline is being followed at the study site and document both the content of the guideline and the actual practices being implemented.

Medication review
Upon consent the PhD candidate will collect the patient’s clinical measures, including weight, body mass index, abdominal girth, and blood pressure, and document these measures in the hospital’s metabolic monitoring chart of the individual patient. Additionally, laboratory investigation results such as blood glucose, lipids (if available with the patient) will be reviewed and compared with the patient’s medical and medication records to monitor metabolic status and to address any other physical health or mental well-being and quality of life issues. Medication charts of the hospital medical records (if needed) and laboratory investigation results will be used from the medical record to conduct the medication review. Any identified issues and recommendations made by the PhD candidate will also be documented in the MAP.

Patient education
All patients will receive both verbal and written education on clozapine, using reputable sources to enhance their knowledge and understanding of the medication (3). The translated information leaflets will be obtained with the necessary approvals and professionally translated through accredited language agencies. The translations and appropriateness or suitability of the content such as available dosage forms in the state sector will be validated by the psychiatrist (one of the supervisors of the PhD candidate) at the study hospital. These leaflets will be used as a guide to educate patients, following the same format observed on the original website (4). Initially patient’s knowledge on clozapine and other medications or their level of understanding of the medications will be assessed by asking simple questions such as “what they are? what are the benefits of taking them? or what will happen if you don’t take them on a regular basis?. Then according to their level of understanding there will be an incremental teaching or education about their medications, such as what are they, why they should take them or the benefits of taking them, what are the possible side effects or what are the side effects commonly reported and how can they manage their side effects if they identify or what they should do if they identify any side effects. Additional tailored education such as non-pharmacological measures to manage side effects, lifestyle modifications will be provided to certain patients based on specific issues identified during their assessment.
This whole appointment will take approximately 30 minutes including history taking, assessing their level of understanding of medications and delivering patient education. One meeting will be conducted with each patient every four weeks for four months.

For each inpatient included in the study, the PhD candidate will visit the patient after their recovery, will try and take best possible medication history, review the medication chart and reconcile the discharge medication list with the hospital records. PhD candidate will also explain the importance of medication persistence, managing side effects, and attending regular follow-ups. The candidate will work to build a strong therapeutic relationship, provide education on clozapine use, and ensure ongoing follow-up with the patient.
References
1. National Medication Management Plan. Accessed at: https://www.safetyandquality.gov.au/our-work/medication-safety/medication-reconciliation/national-medication-management-plan [Internet]. [cited 14.11.2024].
2. PCNE Classification for Drug-Related Problems V9.1. Accessed at: https://www.pcne.org/upload/files/417_PCNE_classification_V9-1_final.pdf [Internet]. [cited 11.11.24].
3. Choice and Medication Patient-Information-Leaflets Queensland Health. Accessed at: https://www.choiceandmedication.org/queenslandhealth/printable-leaflets/patient-information-leaflets/37/ALL/. [cited 21.05.2025].
4. Choice and Medication Patient-Information-Leaflets Queensland Health. Accessed at: https://www.choiceandmedication.org/queenslandhealth/generate/billclozapinearabicau.pdf. [cited 21.05.2025].
Intervention code [1] 331005 0
Treatment: Other
Intervention code [2] 331128 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341565 0
Medication-related problems
Timepoint [1] 341565 0
Any problems identified for 3 months after the first interview
Secondary outcome [1] 447943 0
Clozapine knowledge
Timepoint [1] 447943 0
Baseline and monthly for 3 months (12 weeks) after the first interview
Secondary outcome [2] 447944 0
Side effects of clozapine
Timepoint [2] 447944 0
Baseline and monthly for 3 months (12 weeks) after the first interview
Secondary outcome [3] 447945 0
Medication adherence
Timepoint [3] 447945 0
Baseline and monthly for 3 months (12 weeks) after the first interview
Secondary outcome [4] 447946 0
Mental wellbeing
Timepoint [4] 447946 0
Baseline and monthly for 3 months (12 weeks) after the first interview
Secondary outcome [5] 447947 0
Physical health and Quality of life
Timepoint [5] 447947 0
Baseline and monthly for 3 months (12 weeks) after the first interview

Eligibility
Key inclusion criteria
Inclusion criteria
1. Patients aged 18 years or older who are in the recovery stage after newly starting or restarting clozapine, as directed by the HCPs in the inpatient unit, and patients using clozapine or their carers attending the clinic for routine follow-ups
2. Have the capacity to provide informed consent (verbal)
3. Any gender
4. Able to speak Sinhala/Tamil/English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1. Being unstable or significant distress or physically or emotionally unwell
2. Having severe cognitive impairments and intellectual disabilities as decided by the doctor or those deemed unsuitable for participation in the study by their treating team, and as identified by the PhD candidate or by their carers during the recruitment process

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical Methods and Analysis Plan:

Descriptive statistics (e.g., means, medians, standard deviations, frequencies, and percentages) will be used to summarise demographic and clinical characteristics of participants. Quantitative outcomes (such as medication adherence rates or clinical parameters) will be compared pre- and post-intervention using paired sample t-tests or non-parametric equivalents, depending on data distribution. Categorical variables will be analysed using chi-square or Fisher’s exact tests.
Thematic analysis will be used for qualitative data obtained from interviews, to explore stakeholders' experiences and perceptions of the pharmacist-led intervention.

Sample Size Determination:

Sample for intervention delivery
This unit includes an inpatient unit with 15 male and 15 female patient beds, as well as a weekly clozapine outpatient clinic that serves approximately 70 attendees per month. In general, a feasibility study focuses on evaluating study procedures rather than estimating effect sizes or conducting power calculations, as these are more appropriate for the main trial where outcomes can be more accurately assessed. Consequently, power calculations are typically not performed in feasibility studies (1). For this feasibility study, the sample size was estimated to achieve a reasonable level of confidence in key parameters such as recruitment rates, patient engagement, and data collection processes. For these parameters, a proportional sample size calculation is suitable. This method allows for estimating these key proportions with an acceptable level of precision and confidence. Therefore, using Cochran’s formula, the initial sample size was calculated based on a 95% confidence level and a 5% margin of error, using the following parameters (2,3):
Confidence level: 95% (Z = 1.96)
Margin of error: 5% (E = 0.05)
Proportion (p): 0.5 (used as a conservative estimate)
Sample size: n_0
Using the formula for sample size calculation for estimating proportions:
n_0=(z^2×p×(1-p))/E^2 =((1.96)^2×0.5×(1-0.5))/(0.05)^2 =384·16
Finite population correction (FPC) was applied to adjust for the small population size N=70
n=n_0/(1+(n_(0-1))/N)=384.16/(1+(384.16-1)/70)=59.2
Based on this calculation, the ideal sample size is approximately 60 participants.
Sample for intervention delivery
The sample size was calculated to be 60, based on a 95% confidence level, a 5% margin of error, and an assumed 50% response distribution, adjusted for the finite population of 70 monthly clinic attendees. The researcher will aim to recruit as many participants as possible to manage an expected dropout rate of around 20%.
Adjusted minimum sample size
However, using the methods of Lewis et al.,(4) and Teresi et al.,(1) and considering recruitment limitations such as the number of days that the clinic held and the time duration of the clinic, the sample size was adjusted to a minimum of 35-60 participants.
Sample for service acceptability interviews
All patients, carers, and healthcare professionals (HCPs) (doctors, nurses, and pharmacists) who have personally worked with the researcher as part of the intervention will be invited to participate in the interview. Since the interviews are not in-depth and are expected to last about 20 minutes, it is anticipated that most patients, carers around 12 and 8 HCPs will be interviewed or until data saturation is reached.

(1) Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for designing and evaluating feasibility pilot studies. Med Care. 2022;60(1):95-103.
(2) Pourhoseingholi MA, Vahedi M, M. R. Sample size calculation in medical studies. Gastroenterol Hepatol Bed Bench. 2013;6(1):14-7.
(3) Daniel WW, Cross CL. Biostatistics: a foundation for analysis in the health sciences. 11th ed: Wiley; 2018.
(4) Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!. Pilot Feasibility Stud. 2021;7:1-14.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
10/10/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 27037 0
Sri Lanka
State/province [1] 27037 0
Colombo

Funding & Sponsors
Funding source category [1] 318912 0
University
Name [1] 318912 0
Griffith University
Country [1] 318912 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 321383 0
None
Name [1] 321383 0
Address [1] 321383 0
Country [1] 321383 0
Other collaborator category [1] 283517 0
Hospital
Name [1] 283517 0
Colombo South Teaching Hospital
Address [1] 283517 0
Country [1] 283517 0
Sri Lanka

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317527 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 317527 0
Ethics committee country [1] 317527 0
Australia
Date submitted for ethics approval [1] 317527 0
15/11/2024
Approval date [1] 317527 0
18/02/2025
Ethics approval number [1] 317527 0
2025/074
Ethics committee name [2] 317531 0
Colombo south teaching hospital ethics committee
Ethics committee address [2] 317531 0
Ethics committee country [2] 317531 0
Sri Lanka
Date submitted for ethics approval [2] 317531 0
10/03/2025
Approval date [2] 317531 0
23/04/2025
Ethics approval number [2] 317531 0
4000

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141334 0
Mrs Jegath Janani Tharmalinga Sharma
Address 141334 0
School of Pharmacy and Medical Sciences, Griffith University, Nathan Campus, Building N70 Room 1.10, QLD 4111.
Country 141334 0
Australia
Phone 141334 0
+61 7 37354867
Fax 141334 0
Email 141334 0
[email protected]
Contact person for public queries
Name 141335 0
Jegath Janani Tharmalinga Sharma
Address 141335 0
School of Pharmacy and Medical Sciences, Griffith University, Nathan Campus, Building N70 Room 1.10, QLD 4111.
Country 141335 0
Australia
Phone 141335 0
+61 7 37354867
Fax 141335 0
Email 141335 0
[email protected]
Contact person for scientific queries
Name 141336 0
Jegath Janani Tharmalinga Sharma
Address 141336 0
School of Pharmacy and Medical Sciences, Griffith University, Nathan Campus, Building N70 Room 1.10, QLD 4111.
Country 141336 0
Australia
Phone 141336 0
+61 7 37354867
Fax 141336 0
Email 141336 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approvalhttps://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee   Document attached Document attached Griffith University Ethics approval_Redacted.pdf


Results publications and other study-related documents

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Documents added automatically
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